ADMINISTRATIVE CONTROLS
§ 221.11. Registrant responsibilities.
(a) The registrant is responsible for directing the operation of X-ray systems under his administrative control and shall assure that the requirements of this article are met in the operation of the X-ray systems.
(b) An individual who operates an X-ray system shall be instructed adequately in the safe operating procedures and be competent in the safe use of the equipment. The instructions shall include items included in Appendix A (relating to determination of competence) and there shall be continuing education in radiation safety, biological effects of radiation, quality assurance and quality control.
(1) The operator or the individual who supervises the operation of a high-risk procedure shall have additional instruction, which may include certification or registration in the applicable specialty by a professional organization recognized by the Department. Continuing education for high-risk procedures shall occur, at a minimum, every 2 years.
(2) Continuing education for all other (low-risk) procedures shall occur, at a minimum, every 4 years.
(c) Protocol information, which specifies the techniques for examinations performed with the system, shall be provided in the vicinity of each diagnostic X-ray system’s control panel. The protocol shall include information pertinent to the particular examination, such as:
(1) The patient’s body part and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized.
(2) The type and size of the image receptor or film-screen combination.
(3) The type of grid, if any.
(4) The type and location of placement of patient shielding, for example, gonad, and the like.
(5) For mammography, indication of kVp/target/filter combination.
(6) Source to image receptor distance to be used, except for dental intraoral radiography.
(d) Written safety procedures and rules shall be available at a facility including restrictions of the operating technique required for the safe operation of the particular X-ray system. The operator shall be able to demonstrate familiarity with the rules.
(e) Except for patients who cannot be moved out of the room, only the staff and ancillary personnel or other persons required for the medical procedure or training shall be in the room during the radiographic exposure. The following apply for individuals other than the patient being examined:
(1) Individuals shall be positioned so that no part of the body will be struck by the useful beam unless protected by at least 0.5 millimeter lead equivalent material. The lead equivalent of the material is to be determined at 60 kV.
(2) All persons required for the medical procedure shall be protected from the stray radiation by protective aprons or whole protective barriers of at least 0.25 millimeter lead equivalent or shall be so positioned that the persons are not in the direct line of the useful beam and the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.
(3) A patient who cannot be removed from the room shall be protected from the stray radiation by protective barriers of at least 0.25 millimeter lead equivalent material unless the shield would compromise the health of the individual or shall be so positioned that the patient is not in the direct line of the useful beam and the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.
(4) No individual, other than the patient being examined, may be in the useful beam, unless required to conduct the procedure.
(f) During diagnostic procedures in which the gonads are in the useful beam, gonad shielding of at least 0.5 millimeter lead equivalent shall be used for patients except for cases in which this would interfere with the diagnostic procedure.
(g) An individual may not be exposed to the useful beam except for healing arts purposes or under § 221.15 (relating to use of X-rays in research on humans). An exposure shall be authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:
(1) Exposure of an individual for training, demonstration or other nonhealing arts purposes.
(2) Exposure of an individual for the purpose of healing arts screening except as authorized by the Department. When requesting authorization, the registrant shall submit the information outlined in § 221.13 (relating to information to be submitted by persons requesting approval to conduct healing arts screening).
(h) If a patient or image receptor requires auxiliary support during a radiation exposure the following apply:
(1) Mechanical holding devices shall be used when the technique permits.
(2) The human holder shall be protected as required by subsection (e).
(3) An individual may not be used routinely to hold image receptors or patients.
(i) Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.
(j) The screen and film system used shall be spectrally compatible. Defective screens may not be used for diagnostic radiological imaging.
(k) With the exception of intraoral dental radiography, film may not be used without intensifying screens for routine diagnostic radiological imaging.
(l) The registrant shall have a quality assurance program. This quality assurance program shall be documented and be in accordance with guidelines established by the Department or by another appropriate organization recognized by the Department. At a minimum, the quality assurance program shall address repeat rate, DRLs, image recording, processing and viewing, image quality and artifacts, and maintenance and modifications to the quality assurance program. For CT, each study shall be checked. If an artifact is present, the registrant shall take corrective action as appropriate. Records shall be maintained by the registrant for inspection by the Department for 5 years. The Department’s guidelines and a list of recognized organizations will be maintained and made available on the Department’s website and on request.
(m) Neither the X-ray tube housing nor the collimating device may be handheld during the exposure unless specifically designed to be handheld.
(n) Functional damage to a patient organ or a physiological system that results from a prescribed causative procedure shall be reported to the Department as outlined in § 219.229 (relating to diagnostic or interventional procedure medical reports).
(o) The registrant shall maintain records documenting the QMP’s qualifications and compliance with continuing education requirements.
Authority The provisions of this § 221.11 amended under sections 301 and 302 of the Radiation Protection Act (35 P.S. § § 7110.301 and 7110.302); and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 221.11 adopted February 1, 1972, effective February 2, 1972, 2 Pa.B. 212; amended December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; amended October 2, 1998, effective October 3, 1998, 28 Pa.B. 4894; amended November 16, 2001, effective November 17, 2001, 31 Pa.B. 6282; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823; amended October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791. Immediately preceding text appears at serial pages (333934), (304487) to (304488) and (333935).
Cross References This section cited in 25 Pa. Code § 221.35a (relating to fluoroscopic X-ray systems); and 25 Pa. Code § 221.42a (relating to control of scattered radiation).
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